Sydney, Australia-based Recce Pharmaceuticals reported positive findings from its phase 2 study examining the efficacy and safety of its topical gel, R327G (RECCE 327), in patients with acute bacterial skin and skin structure infections (ABSSSI), including those with diabetic foot infections (DFI). R327G demonstrated a 93% primary efficacy endpoint over 14 days, meeting all study endpoints.
“These impressive results underscore the potential of our topical gel to meet critical unmet medical needs in infection treatment,” Recce Pharmaceuticals CEO James Graham, said in a statement. “As we advance towards registrational phase 3 trials in Indonesia and Australia, we are encouraged by the rapid efficacy and strong safety outcomes demonstrated in this study."
Study Specifics and Takeaways
The study enrolled 30 patients. Of those, 29 were included in the final data analysis. One patient was withdrawn due to pre-existing pain at the wound site that was deemed unrelated to R327G. The study achieved all primary and secondary endpoints as an open-label clinical trial evaluating the safety, tolerability, efficacy, and plasma pharmacokinetics of R327G when applied directly to the infected area.
What You Need to Know
Recce Pharmaceuticals' topical gel, R327G, achieved a 93% primary efficacy endpoint over 14 days in treating acute bacterial skin and skin structure infections (ABSSSI), including diabetic foot infections (DFI).
Encouraged by the strong phase 2 results, the company is advancing towards phase 3 trials in Australia and Indonesia, with regulatory approvals in place.
R327G aligns with global efforts to combat AMR, as emphasized by the FDA’s demand for novel broad-spectrum antibiotics.
The study included men and women with a minimum age of 18 years old and no maximum age limit. After 7 days of treatment, 86% of patients (25 out of 29) treated with R327G had a successful clinical response. At 14 days of treatment, 93% of patients (27 out of 29) achieved a primary efficacy endpoint. R327G demonstrated to be safe and well tolerated, with no serious adverse events (SAE) reported, achieving all endpoints.
Read more: Recce Pharmaceuticals Advances Antibiotic Development to Combat Antimicrobial Resistance
Reece says the data received from this trial aligns with the FDA’s increased demand for novel broad-spectrum antibiotics to address antimicrobial resistance (AMR). ABSSSIs are a significant healthcare concern, encompassing indications such as DFI, necrotizing fasciitis, and post-operative wound infections. There are no ABSSSI placebo-controlled studies as international regulators deem withholding appropriate treatment of patient infections unethical.
In a previous interview with Contagion, Graham discussed the makeup of the product. “Our compound is entirely synthetic. We started with first principles, designing a compound that remains effective with repeated use.”2
Next Steps
The company says the data supports potential commercialization for the gel and are moving towards a phase 3 trial in Australia for ABSSSI and DFI. Driven by the high response rates in this study, it has been determined the company’s current registrational phase 3 study for DFI can meet a statistically significant positive endpoint after completing approximately 100 patients compared to the study baseline of 300 patients. The Indonesian Drug and Food Regulatory Authority (Badan POM) approved protocol has a built-in interim analysis. Recce anticipates completing this data set by the end of the year.
“These results reflect the broad-spectrum nature and rapid onset of the effect of R327G, which positions us well for the upcoming phase 3 trials in Indonesia and Australia,” Recce Director and Chief Medical Advisor Alan Dunton, MD, said in a statement.
References
1. Recce Pharmaceuticals Reports Positive Data from Phase II Trial of RECCE® 327 Gel in Acute Bacterial Skin and Skin Structure Infections, Supporting Accelerated Commercialization Pathway. Recce press release. February 19, 2025. Accessed February 19, 2025.
https://www.globenewswire.com/news-release/2025/02/19/3028726/0/en/Recce-Pharmaceuticals-Reports-Positive-Data-from-Phase-II-Trial-of-RECCE-327-Gel-in-Acute-Bacterial-Skin-and-Skin-Structure-Infections-Supporting-Accelerated-Commercialization-Path.html
2. Abene S. Recce Pharmaceuticals Advances Antibiotic Development to Combat Antimicrobial Resistance. Contagion. September 7, 2024. Accessed February 19, 2025.
https://www.contagionlive.com/view/reece-pharmaceuticals-advances-antibiotic-development-to-combat-antimicrobial-resistance
